What to Toss and When to Call a Doctor

• More than 3.1 million bottles of over-the-counter eye drops are being recalled due to concerns about sterility.
• While no illnesses have been reported, experts say recalls like this can erode public trust in medicine.
• A 2023 outbreak linked to eye drops resulted in more than 80 infections and four deaths in the United States.

A California-based pharmaceutical company is recalling more than 3.1 million bottles of eye drops due to concerns about sterility.

According to a report by the Food and Drug Administration (FDA), K.C. Pharmaceuticals is conducting a voluntary recall of the products distributed through major national retailers, including Walgreens, Kroger, and CVS.

The recall was initiated on March 3 and classified by the FDA on March 31. The FDA safety alert reflects both uncertainty and caution, according to experts.

“We don’t know if they really were contaminated. If they were, we don’t know what type of microbe. We don’t know any of that. All we know is that the manufacturer said there’s an issue with sterility in these products,” said Gary Novack, PhD, a clinical professor in the UC Davis Department of Ophthalmology and Vision Science and a consultant in ophthalmic product development.

There have been no reported injuries or illnesses related to the recalled products, which include:

• Sterile Eye Drops AC
• Eye Drops Advanced Relief
• Dry Eye Relief Eye Drops
• Ultra Lubricating Eye Drops
• Sterile Eye Drops Original Formula
• Sterile Eye Drops Redness Lubricant
• Sterile Eye Drops Soothing Tears
• Artificial Tears Sterile Lubricant Eye Drops

Consumers are urged to discontinue use and discard these products.

The FDA classified the recall as a “Class II” recall, meaning that “using the drug may cause temporary health consequences, but the probability of a serious health issue is remote,” an FDA representative told Healthline. The rationale for the recall is listed as “lack of assurance of sterility.”

That designation does not mean there is proof of contamination, but rather that there has been a potential lapse in the manufacturing process that could compromise sterility.

Retailers are working to address the recall and guide customers on the next steps. Healthline reached out to a number of them.

Walgreens and Kroger did not respond by the time of publication, but a representative for CVS said, “We’re committed to ensuring the products we offer are safe, work as intended, comply with regulations, and satisfy customers’ needs. While the four recalled items sold by CVS were discontinued nearly a year ago, we’re fully cooperating with the voluntary recall.”

The CVS representative added that customers who purchased these products may return them for a refund.

Although no illnesses have been reported due to the recall, experts say that widespread recalls do other kinds of damage.

“It’s always concerning any time we have a recall of clinical products,” said Sylvia Groth, MD, executive medical director, Department of Ophthalmology, Vanderbilt University Medical Center, and associate professor of Ophthalmology, Vanderbilt University Medical Center.

“These events erode patient trust in over-the-counter medications. I am concerned that when I prescribe or recommend a treatment, it can be undermined by a recall,” she said.

Prescription eye drops are not part of the current recall, and anyone using these medications should feel safe and confident continuing their course.

“They’re not at risk,” said Novack. “We don’t want patients to stop using their prescription eye drops for glaucoma, dry eye, or infection. It doesn’t apply to them.”

Novack, who wrote about the outbreak in the journal Ophthalmology, called the incident a “perfect storm,” made possible by multiple points of failure.

He pointed to multiple points of failure, including:

• The manufacturer sold a product that didn’t comply with federal regulations; the facility was contaminated with the antibiotic-resistant bacteria Pseudomonas aeruginosa.
• During the COVID-19 pandemic, the FDA temporarily paused inspections of domestic and foreign manufacturing sites, potentially allowing lapses in manufacturing safety to go undetected.

If you’ve purchased one of the recalled products listed above and concerned about an potential eye infection look for the following signs and symptoms:

• discharge from the eye
• pain or discomfort
• redness or inflammation
• blurry vision

However, these symptoms are often nonspecific, meaning they can be caused by a number of issues, including allergies, Groth said.

“Patients can get very bad allergies, especially this time of year, that can mimic an infection in the eye. If it is actually an allergy-based reaction, that can be bothersome and irritating, but not something that needs any additional treatment or antibiotics,” she noted.

She added that it’s important to track symptom progression, and if they aren’t improving, it may be time to see a doctor.

People who wear contacts should be especially mindful of symptoms.

“In general, I’m always more worried about my contact lens population than an otherwise healthy person using artificial tears. If you’re a contact lens wearer, you’re at higher risk because you can have small, unrecognized abrasions or small ulcers that are present, and contact lenses can hold bacteria on them that other patients don’t have in their eyes,” Groth said.

Here are some best practices when applying eye drops:

• Wash your hands.
• Avoid touching your eye or eyelashes with the tip of the bottle.
• Discard single-use products immediately after use.
• Look for reputable brand names or get a doctor’s recommendation.